For Immediate Release
April 19, 2016
Contact
Consumers
Pharmakon Pharmaceuticals, Inc.888-660-6715
Announcement
Pharmakon Pharmaceuticals, Inc. is voluntarily recalling all lots
of sterile products aseptically compounded and packaged by Pharmakon
Pharmaceuticals, Inc. that remain within expiry due to the Food and Drug
Administration’s (FDA) concern over a lack of sterility assurance and
other quality issues. Administration of a sterile drug product intended
to be sterile that is compromised may result in serious and potentially
life-threatening infections or death. To date, Pharmakon
Pharmaceuticals, Inc. has not received any reports of adverse effects or
injuries.
These compounded sterile products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
As Pharmakon Pharmaceuticals, Inc. takes the utmost care to ensure patient safety and out of an abundance of caution, then, Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products. All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, to take the following actions:
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Again, Pharmakon Pharmaceuticals, Inc.’s primary concern is your safety and Pharmakon Pharmaceuticals, Inc. is taking this action out of an abundance of caution. Thank you for your support.
These compounded sterile products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
As Pharmakon Pharmaceuticals, Inc. takes the utmost care to ensure patient safety and out of an abundance of caution, then, Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products. All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, to take the following actions:
- Discontinue use of the products
- Quarantine any unused product
- Contact Pharmakon Pharmaceuticals, Inc. at 888-660-6715 x251 from the hours of 8:30am 5:00pm Eastern Standard Time Monday-Friday to discuss the return of any unused sterile compounded products
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Voluntary Product Recall List: https://pharmakonmfg.net/pr/
Again, Pharmakon Pharmaceuticals, Inc.’s primary concern is your safety and Pharmakon Pharmaceuticals, Inc. is taking this action out of an abundance of caution. Thank you for your support.
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Page Last Updated: 04/19/2016
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